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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03050697
Registration number
NCT03050697
Ethics application status
Date submitted
14/09/2016
Date registered
13/02/2017
Titles & IDs
Public title
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
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Scientific title
A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery
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Secondary ID [1]
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CP-00004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aphakia
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Corneal Astigmatism
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Cataract
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - HARMONI® Modular Toric Intraocular Lens
Treatment: Surgery - Cataract extraction with intraocular lens (IOL) implantation
Experimental: HMTIOL - HARMONI® Modular Toric Intraocular Lens implanted in the capsular bag following removal of the cataractous lens, intended for lifetime use
Treatment: Devices: HARMONI® Modular Toric Intraocular Lens
Two-component system consisting of a base and a separate toric optic
Treatment: Surgery: Cataract extraction with intraocular lens (IOL) implantation
Cataract removal via manual phacoemulsification, followed by HMTIOL implantation
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
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Assessment method [1]
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A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number, with a less negative number indicating a lesser amount of added correction. No formal statistical hypothesis testing was planned.
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Timepoint [1]
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Month 1 postoperative, Month 3 postoperative
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Primary outcome [2]
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Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
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Assessment method [2]
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A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. MRCYL PE was calculated as postoperative MRCYL adjusted to 6 meters minus MRCYL target residual refractive error (TRRE), with a lower absolute value indicating a more accurate cylinder power calculation. No formal statistical hypothesis testing was planned.
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Timepoint [2]
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Month 1 postoperative, Month 3 postoperative
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Primary outcome [3]
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MRCYL PE for Eyes Implanted With HMTIOL Per Vector Analyses
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Assessment method [3]
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Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL PE is calculated as postoperative MRCYL adjusted to 6 meters minus MRCYL target residual refractive error (TRRE), with a lower absolute value indicating a more accurate cylinder power calculation. No formal statistical hypothesis testing was planned.
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Timepoint [3]
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Month 1 postoperative, Month 3 postoperative
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Primary outcome [4]
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Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL
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Assessment method [4]
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A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. No formal statistical hypothesis testing was planned.
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Timepoint [4]
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Baseline (Day 0 preoperative), Month 3 postoperative
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Primary outcome [5]
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Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL
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Assessment method [5]
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A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. Therefore, the cylindrical power percent reduction was the cylinder power reduction divided by the absolute value of preoperative magnitude of corneal cylinder (K) × 100. A higher number (greater percent reduction) indicates better astigmatism correction by the toric IOL. No formal statistical hypothesis testing was planned.
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Timepoint [5]
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Baseline (Day 0 preoperative), Month 3 postoperative
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Primary outcome [6]
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Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
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Assessment method [6]
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A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). MRSE PE was calculated as postoperative MRSE adjusted to 6 meters minus MRSE target residual refractive error (TRRE). The lower the absolute number, the more accurate the IOL power calculation is. No formal statistical hypothesis testing was planned.
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Timepoint [6]
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Month 1 postoperative, Month 3 postoperative
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Primary outcome [7]
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Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative Visit
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Assessment method [7]
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Absolute misalignment of IOL meridian was defined as the summation of IOL misplacement and IOL rotation. A lower number indicates minimal IOL misalignment. No formal statistical hypothesis testing was planned.
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Timepoint [7]
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Day 0 (operative)
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Primary outcome [8]
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Mean Absolute Rotation of IOL Meridian by Visit
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Assessment method [8]
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IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees. No formal statistical hypothesis testing was planned.
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Timepoint [8]
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Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
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Primary outcome [9]
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Number of Eyes With Absolute Rotation of IOL Meridian by Visit
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Assessment method [9]
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IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned.
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Timepoint [9]
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Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
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Primary outcome [10]
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Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
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Assessment method [10]
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Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. BCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
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Timepoint [10]
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Baseline (Day 0 preoperative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
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Primary outcome [11]
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Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
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Assessment method [11]
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Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). UCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
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Timepoint [11]
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Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
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Primary outcome [12]
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Standard Error of the Mean in Lens Power A-constant for Refinement
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Assessment method [12]
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The A-constant (lens power constant) is a theoretical value that is used to calculate the power of the intraocular lens. It relates the lens power to the eye's axial length and keratometry. It is not expressed in units; it is specific to the design of the IOL and its intended location and orientation within the eye.
A-constants are typically empirically developed for new IOLs based on hundreds of clinical uses. Data from a sufficient number of eyes are needed in order to reduce bias due to surgical technique, unusual eyes, and differences in equipment, such that the standard error of the mean in the lens power constant would be less than ±0.10 mm (approximately ±0.2 diopter). This study represented the first clinical use of the HMTIOL.
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Timepoint [12]
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Day 0 operative
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Primary outcome [13]
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Number of Ocular Adverse Events Through Month 3
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Assessment method [13]
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Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned.
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Timepoint [13]
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Up to Month 3 postoperative
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Primary outcome [14]
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Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL
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Assessment method [14]
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A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes. No formal statistical hypothesis testing was planned.
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Timepoint [14]
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Up to Month 3 postoperative
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Primary outcome [15]
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Number of Device Deficiencies Post Implantation
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Assessment method [15]
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A device deficiency was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned.
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Timepoint [15]
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Up to Month 3 postoperative
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Primary outcome [16]
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Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
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Assessment method [16]
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Preservation of BCDVA was defined in terms of lines lost when reading the ETDRS chart at each visit compared to the prior best-achieved BCDVA. Loss of \< 1 line included subjects with less than a 1 line loss, no change or improvement in BCDVA. No formal statistical hypothesis testing was planned.
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Timepoint [16]
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Month 1 postoperative, Month 3 postoperative
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Eligibility
Key inclusion criteria
Key
* Planned removal of visually significant bilateral cataract by manual phacoemulsification cataract extraction
* Pre-existing corneal astigmatism in at least 1 eye of 0.75 to 2.50 diopter (D)
* Target dioptric lens power within the range of 16 - 26 D
* Willing to discontinue contact lens wear for the duration of the study
* BCVA projected to be =0.2 logarithm minimum angle of resolution (LogMAR)
* Stable cornea
* Dilated pupil size at least 7.0 millimeters (mm)
* Able to understand and provide informed consent.
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Minimum age
22
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of any intraocular or corneal surgery in study eye (including refractive)
* Pregnant or lactating
* History of any clinically significant retinal pathology or ocular diagnosis in study eye that could alter or limit final postoperative visual prognosis
* History of ocular conditions which could affect the stability of the IOL in study eye
* Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction in study eye
* Any visually significant intraocular media opacity other than cataract in study eye
* Uncontrolled glaucoma in study eye
* Uncontrolled systemic disease
* Severe dry eye that would impair the ability to obtain reliable study measurements
* Systemic medication that may confound the outcome or increase the intraoperative and postoperative risk to the subject.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/09/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/07/2017
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ClarVista Medical
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.
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Trial website
https://clinicaltrials.gov/study/NCT03050697
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sr. Clinical Trial Lead, CDMA Surgical
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Address
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Alcon Research, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/97/NCT03050697/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/97/NCT03050697/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03050697